Acute Myeloid LeukemiaPhase 1NCT00964873
A Phase 1 Study of the HSP90 Inhibitor, STA-9090 in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia
A Phase 1 study testing STA-9090 (ganetespib) in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Synta Pharmaceuticals Corp. at 3 sites in United States.
Trial summary
An open-label phase 1 study to assess safety and efficacy of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia
- What is being tested?
- STA-9090 (ganetespib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2009to Aug 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a pathologic confirmation of the diagnosis of AML, ALL, or blast-phase CML
- ECOG Performance Status 0-2
- Adequate organ function as defined in the protocol.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Hyperleukocytosis
- Acute Promyelocytic Leukemia (FAB-M3) subtype
- Uncontrolled Disseminated Intravascular Coagulation (DIC)
- Active central nervous system leukemia
- Concomitant radiation therapy, chemotherapy, or immunotherapy
- Women who are pregnant or lactating
Show all 11Show fewer
- Neuropathy ≥ grade 2 (NCI CTCAE) at time of enrollment
- Chemotherapy (with the exception of hydroxyurea) or radiotherapy within two weeks or within six times the agent's half life
- Require ongoing therapy with either G- or GM-CSF, or long-acting versions of these molecules
- Use of any investigational agents within two weeks or within six times the agent's half life --Treatment with chronic immunosuppressants
- Other medical/psychiatric condition that may increase the risk associated with study participation as defined by the protocol.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Baltimore, Maryland, 21231
Study site
Durham, North Carolina, 27710
Study site
Tampa, Florida, 33612
About this study
Official title: A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia
An open-label phase 1 study to assess safety and efficacy of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia, AML, ALL, CML
- Being tested
- STA-9090 (ganetespib)
- Keywords
- Synta, STA-9090, ganetespib, Hematologic Cancers, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia, AML, ALL, CML, HSP90 Inhibitor
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Blast Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA-9090 (ganetespib)Drug
Chemotherapy agent
| Study group | Role | What they receive |
|---|---|---|
| 1 Part 1 | Experimental | Not described Receives: Drug: STA-9090 (ganetespib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria
Measured: every 8 weeks
Secondary outcomes (1)
To characterize the safety and tolerability of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML
as per adverse event and serious adverse event reporting
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synta Pharmaceuticals Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964873
- Sponsor's protocol ID
- 9090-04
- Status last verified
- Sep 2014
- First submitted
- 24 Aug 2009
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT00964873
- Acronym / sponsor ID
- 9090-04
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia, AML, ALL, CML
- Keywords
- Synta, STA-9090, ganetespib, Hematologic Cancers, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia, AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label phase 1 study to assess safety and efficacy of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 Part 1 | Experimental | Drug: STA-9090 (ganetespib) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with a pathologic confirmation of the diagnosis of AML, ALL, or blast-phase CML
- ECOG Performance Status 0-2
- Adequate organ function as defined in the protocol.
- Ability to understand and willingness to sign a written informed consent document.
Key exclusion criteria (11 listed)
- Hyperleukocytosis
- Acute Promyelocytic Leukemia (FAB-M3) subtype
- Uncontrolled Disseminated Intravascular Coagulation (DIC)
- Active central nervous system leukemia
- Concomitant radiation therapy, chemotherapy, or immunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STA-9090 (ganetespib)Chemotherapy agent | Drug | 1 Part 1 |
Primary outcome
To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria
Time frame: every 8 weeks
1 secondary outcome
To characterize the safety and tolerability of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STA-9090 (ganetespib) in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Synta Pharmaceuticals Corp. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria (time frame: every 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.